Active Member
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[China]
Address: Office Address: Building 4, No. 51 Jingbei 3rd Road, Jingkai Zone, Zhengzhou City. Henan Province,China.
Contact name:chen
Henan Lantian Medical Supplies Co.,Ltd. |
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The kit was used to determine the quality of antibodies and
antibodies in human serum, plasma, and whole blood.
Novel crown virus is a new type of corona virus which belongs to
the genus Beta. can cause viral pneumonia, the main clinical
manifestations are fever, fatigue, dry cough, few patients have a
stuffy nose, sore throat, diarrhea. In severe cases, there are
respiratory problems and low levels or hypoxia after one week.
Severe cases include acute respiratory distress syndrome, septic
shock, metabolic acidosis that is difficult to correct, bleeding
and coagulation disorders.
The new type of corona virus has various structural proteins: crest
protein, E protein, membrane protein, and nuclear protein.
Receptor-associated proteins bind domains responsible for
identifying receptors on the cell surface. The results revealed a
strong interaction between RBD's 2019 ncv spike protein and the
human ACE2 receptor that engulfs host cells and pulmonary viruses.
After 2019 years of infection or vaccination, it triggers an immune
reaction and produces antibodies in the blood. It secretes
anti-viral antibodies that are present in the circulating system of
the infected human body for months or years and are rapidly and
closely linked to pathogens to protect against viruses. These
antibodies are known as neutralizing antibodies. Neutralizing
antibodies can check whether people have the ability to protect
against viral infections.
The kit includes a test card and a sample buffer solution.
The test card consists of a dry aluminum foil bag, a test strip,
and a blister card. The test strip consisted of nitrocellulose
absorbent paper, sample film, adhesive sheet and rubber sheet. The
T line was coated with ACE2 protein, the C line was coated with
antibody, the R line was coated with a control antibody, and the
2019 ncv antigen was marked.
For example, phosphate buffer, sodium oxide, etc.
It is stored for months at temperature.
The shelf life of the aluminum foil bag is one hour after opening
the box.
See the product label for more details.
Product expiration date, see label for more details.
Read the instructions carefully before testing. Please recall all chemicals at room temperature before testing and test at room temperature.
Figure for judging test card results:
1. Incorrect result, no reaction on line C, test is invalid and
should be repeated.
2. Negative result, line T shows a red bar greater than or equal to
control line C and line R.
3. Positive results: The T-line or T-line does not have a red band,
but its color appears lower than the control line C and the control
line.
1.This kit is a qualitative test and is only used for in vitro
diagnostic support.
2. Make sure that the correct number of samples is added for
testing. Too large or too small a sample may lead to inaccurate
results.
3. Hemolysis, lipidemia, jaundice, and contaminated specimens may
affect test results, so avoid these specimens.
4. Test results for this reagent are for clinical use only and
should not be used as the sole basis for clinical diagnosis and
treatment. The final diagnosis of the disease should be made after
a comprehensive evaluation of all clinical and laboratory results.
1. Analysis of specificity
1.1 Cross-reaction: Interference with the following types of
antibodies was assessed with the reagents and the results showed
that there was no cross-reaction.
| SN | Item | Cross reaction | SN | Item | Cross reaction |
| 1 | Endemic human coronavirus OC43 | No | 10 | Enterovirus | No |
| 2 | Endemic human coronavirus HKUI | No | 11 | EB virus | No |
| 3 | Endemic human coronavirus NL63 | No | 12 | Measles virus | No |
| 4 | Endemic human coronavirus 229E | No | 13 | Human cytomegalovirus | No |
| 5 | Influenza A virus | No | 14 | Rotavirus | No |
| 6 | Influenza B virus | No | 15 | Norovirus | No |
| 7 | Respiratory syncytial virus | No | 16 | Mumps virus | No |
| 8 | Adenovirus | No | 17 | Varicella-zoster virus | No |
| 9 | Rhinovirus | No | 18 | Mycoplasma pneumoniae | No |
1.2 Interfering Substances: The following substances were added to
the samples at specific concentrations and assessed for their
potential interference with the design of the novel coronavirus
neutralizing antibody test (2019-nCoV). The results show that
different interfering substances will not interfere with the
detection results of this reagent.
| Interfering substances | Concentration | Interfering substances | Concentration |
| Bilirubin | ≤50mg/dL | Triglycerides | ≤15mmol/mL |
| Hemoglobin | ≤5g/L | Cholesterol L | ≤500mg/d |
| Rheumatoid factor | ≤500IU/mL | Human total IgG | ≤14mg/mL |
| Ribavirin | 0.4mg/mL | Fluticasone | 0.5mg/mL |
| Oxymetazoline | 10mg/mL | Dexamethasone | 5 mg/mL |
| Histamine hydrochloride | 10mg/mL | Triamcinolone acetonide | 5mg /mL |
| Tobramycin | 1mg/mL | Levofloxacin | 0.2 mg/mL |
| Oseltamivir | 1mg/mL | Azithromycin | 0.1 mg/mL |
| Zanamivir | 1mg/mL | Ceftriaxone | 0.4 mg/mL |
| Arbidol | 0.5mg/mL | Meropenem | 0.2 mg/mL |
2. Clinical studies: Using the new Coronavirus (2019-nCoV) IgG Antibody Detection Reagent (colloidal gold method) as contrast reagent, 120 positive and 300 negative samples were selected for detection, respectively, and the results were summarized as follows:
2019-nCoV IgG Ab detection reagent (colloidal goldmethod) |
Sum | |||
| Positive | Negative | |||
| Positive | 115 | 5 | 120 |
| Negtive | 5 | 295 | 300 | |
| Sum | 120 | 300 | 420 | |
| Sensitivity | 95.83%, (95%CI: 90.62%～98.21%) | |||
| Specificity | 98.33%, (95%CI: 96.16%～99.29%) | |||
1. This product is for in vitro diagnostic use only.
2. This product is disposable and cannot be recycled after use.
3. Before the operation, carefully read the instruction manual and
perform the experimental operation in accordance with the reagent
instruction manual.
4. Avoid harsh environments (such as environments containing high
concentration corrosive gases and dust, such as disinfectant,
sodium hypochlorite, acid, alkali, or acetaldehyde). After the
experiment is completed, laboratory disinfection should be
performed.
5. All specimens and used reagents should be handled as potentially
infectious and should be disposed of in accordance with local
regulations in case of rejection.
6. Please use the reagent within the expiry date marked on the
outer carton, and use the test card as soon as possible after
removing it from the aluminum foil bag to prevent moisture.
| Do not re-use |
| Store at 2℃～30℃ |
| Consult instructions for use |
| In vitro diagnostic medical device |
| Batch code |
| Use-by date |
 | Keep dry |
| Keep away from sunlight |
| Authorized representative in the European Community |
| Manufacturer |
ZHONGXIU SCIENCE AND TECHNOLOGY CO.,LTD
Dingluan industrial zone ,Changyuan City,453400,P.R.CHINA
Tel:+86-371-55016575
Email:zosbio@zosbio.com
Web:www.zosbio.com
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Olympisch Stadion 24, 1076DE Amsterdam, Netherlands
